7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part #
FDA device recall Z-2490-2015 · posted 2015-08-31 · Terminated
Recall details
- Recalling firm
- Trilliant Surgical Ltd.
- Reason for recall
- The affected parts subject to the recall are out of specification, resulting in in the loss of the optimal locking screw functionality of the plates. The thread depth of the screw holes is insufficient, potentially limiting the ability to engage and lock with associated mating locking screws.
- Action taken
- Trilliant Surgical sent an Urgent Medical Device Recall letter dated August 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed and confirmed consignees to discontinue use of the affected lots, quarantine, and return product (if not yet done so) in accordance with an included acknowledgement sheet. For further questions, please call 1(800) 495-2919 , 8:00am - 5:00pm CST
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 28 units
- Distribution
- US Distribution to the states of : FL, OH, NJ, MN, WI, NM and CA.
- Date initiated
- 2015-08-06
- Date posted
- 2015-08-31
- Date terminated
- 2017-01-26
- Location
- Houston, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GRIDLOCK PLATING SYSTEM (K121452) | Trilliant Surgical, Ltd. | 2012-08-20 |